| | TABLE OF CONTENTS: LIST OF ILLUSTRATIONS ix
LIST OF TABLES xi
ACKNOWLEDGMENTS xiii
LIST OF ABBREVIATIONS AND ACRONYMS xvii
INTRODUCTION: The Gatekeeper 1
CHAPTER ONE: Reputation and Regulatory Power 33
PART ONE: ORGANIZATIONAL EMPOWERMENT AND CHALLENGE
CHAPTER TWO: Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath 73
CHAPTER THREE: The Ambiguous Emergence of American Pharmaceutical Regulation, 1944-1961 118
CHAPTER FOUR: Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961-1966 228
CHAPTER FIVE: Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963-1986 298
CHAPTER SIX: Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977-1992 393
PART TWO: PHARMACEUTICAL REGULATION AND ITS AUDIENCES
CHAPTER SEVEN: Reputation and the Organizational Politics of New Drug Review 465
CHAPTER EIGHT: The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite 544
CHAPTER NINE: The Other Side of the Gate: Reputation, Power, and Post-Market Regulation 585
CHAPTER TEN: The Détente of Firm and Regulator 635
CHAPTER ELEVEN: American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies 686
CHAPTER TWELVE: Conclusion: A Reputation in Relief 727
PRIMARY SOURCES AND ARCHIVAL COLLECTIONS 753
INDEX 759
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